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U.S. Department of Health and Human Services

Class 2 Device Recall Expression MR200 MRI Patient Monitoring System

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  Class 2 Device Recall Expression MR200 MRI Patient Monitoring System see related information
Date Initiated by Firm September 08, 2014
Date Posted October 01, 2014
Recall Status1 Terminated 3 on January 09, 2017
Recall Number Z-0001-2015
Recall Event ID 69192
510(K)Number K131382  
Product Classification Monitor,physiological,patient(without arrhythmia detection or alarms) - Product Code MWI
Product Philips Expression MR200 MRI Patient Monitoring System Model 866120
Code Information Model 866120 with the following lots #'s: US33600006, US33600007, US33600011, US33600012 and US33600013
Recalling Firm/
Manufacturer		 Invivo Corporation
12151 Research Pkwy
Suite 200
Orlando FL 32826-3222
For Additional Information Contact Debra Levasseur
407-275-3220 Ext. 171
Manufacturer Reason
for Recall		 During production, excess metal (aluminum) debris was found stuck to the cling plastic that covers the device's pole assembly. The metallic debris could affect system performance due to the potential for a failure to power up or loss of power. This could result in the loss of monitoring and a delay in diagnosis of the patient.
FDA Determined
Cause 2		 Material/Component Contamination
Action The firm, Philips Healthcare, sent an "URGENT- Medical Device Recall" letter dated June 17, 2014, to its customers informing them of the product, problem and actions taken. The firm informed the customers that there are no additional actions required on their part. The Philips/Invivo Account Manager will contact them in order to arrange for replacement of the device. If you need any further information or support concerning this issue, contact your local Philips/Invivo representative: 877-468-4861 option 1, then option 2.
Quantity in Commerce 10 units
Distribution Worldwide Distribution: US distribution in state of: CA and countries of: Poland, Singapore, and Sweden.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MWI and Original Applicant = INVIVO CORPORATION
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